Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2111760

FEI Number

2111760

Entity Name

Scribe Opco, LLC

City/State/Country

RED WING, MN, US

Establishment Address

5151 Moundview Dr, RED WING, MN 55066, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SCRIBE OPCO, INC., dba Koozie Group (Owner Number: 9010937)

Owner / Operator Contact Address

5151 Moundview Drive, Red Wing, MN 55066, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

40069 Custom Printed White Bandages Norwood Adhesive Bandages Stock 40070 Custom Printed Tattoo Bandages NORWOOD-WASHBURN LABORA 41163 - Digital Thermometer Protector Hearing Insert Sunglasses 40730 First Aid Kit For Burns 40122 Travelin Companion 40729 Sport Kit 40011 Pocket First Aid Kit 40039 Translucent Personal First Aid Kit 40731 Recovery Kit 40047 Personal First Aid Kit 40429 Frosty Clipper First Aid Kit 40728 Jet Setter Kit 40626 Montana Cross First Aid Kit 40382 Redi First Aid Pack 40045 Deluxe First Aid Kit 40049 First Aid Wallet 40399 Family Pack First Aid Kit 20417 Retro First Aid Tin 40397 Basic First Aid Kit 40512 Frosty Stripe First Aid Kit 40101 Sports Injury First Kit 40625 Montana First Aid Kit 40044 Compact First Aid Kit 40472 Carabiner First Aid Kit 40162 Pain Relief Pocket Pack 40343 First Care Kit 40040 First Aid Pouch 3 PLY DISPOSABLE MASK Face Shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	1998-03-16
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-11-23
EWD	Protector, Hearing (Insert)	Unknown	Class U	N/A	2007-12-06
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	2001-07-06
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2007-12-06
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-07
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-05-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SCRIBE OPCO, INC., dba Koozie Group

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2111760. Last updated year: 2026. Please use registration number 2111760 when referencing this establishment in official correspondence.